1. Factors influencing renal function in patients receiving telaprevir twice daily or every 8 hours: Results from the phase III optimize study.
- Author
-
Rizzetto M., Demasi R., Luo D., Bertelsen K., Witek J., Brown Jr. R.S., Hezode C., Parana R., Buti M., Agarwal K., Horsmans Y., Sievert W., Janczewska E., Zeuzem S., Nyberg L., De Meyer S., Rizzetto M., Demasi R., Luo D., Bertelsen K., Witek J., Brown Jr. R.S., Hezode C., Parana R., Buti M., Agarwal K., Horsmans Y., Sievert W., Janczewska E., Zeuzem S., Nyberg L., and De Meyer S.
- Abstract
Background and Aims: OPTIMIZE confirmed that telaprevir twice daily (bid) plus pegylated interferon-alfa (P) and ribavirin (R) was noninferior to every 8 hours (q8h) for SVR12 in treatmentnaive patients with genotype 1 chronic HCV infection. Decreased glomerular filtration rate (GFR) may occur with PI-based triple therapy. We examined the effect of telaprevir and comorbidities on GFR during and post treatment. Method(s): Patients (screening creatinine clearance >=50 mL/min) received telaprevir bid or q8h for 12 weeks, then PR for 12/36 weeks. GFR (Cockcroft-Gault) was measured at baseline, and regularly during Weeks 1-12 and post-telaprevir treatment (Weeks 12-48) in the overall treatment phase. Each patient's lowest GFR recorded during each phase of the study was used. Result(s): At baseline, mean(SD) GFR was 110.5(31.5) mL/min (n = 739). GFR decreased in both treatment groups during telaprevir treatment (bid: -15 mL/min; q8h: -14 mL/min; P = 0.40), but returned to baseline levels post telaprevir (bid: 0 mL/min; q8h: -1.1 mL/min) by Week 13. Similar numbers of patients had GFR <60 mL/min (bid: 41/365 versus q8h: 40/368; P = 0.91), mostly during the telaprevir treatment phase (bid: 40/41; q8h: 38/40). GFR reductions were slightly greater with advanced fibrosis stage during and post telaprevir (Table 1). Greater GFR reductions from baseline during telaprevir treatment occurred in patients with diabetes (P = 0.026), hypertension (P <0.001) or those receiving ACE inhibitors (P = 0.002) versus those without. Conclusion(s): GFR decreased during telaprevir treatment and was <60 mL/min in 11% of patients. GFR returned to baseline levels following telaprevir completion. Advanced fibrosis and comorbidities contributed to decreases in GFR in the presence of telaprevir. (Table Presented).
- Published
- 2014